The present invention relates to devices for supporting and positioning infants. More specifically, the present invention is for use by premature or ill infants, who may have special developmental requirements which can be improved through proper support and positioning.
Improvements in medical technology have been increasing the overall survival rate of prematurely born infants or infants born with medical complications. While general medical technology has provided the means to help the infants survive, such infants still encounter developmental problems which occur as a result of their delicate condition. Their developmental problems may be exacerbated by the prolonged period of time which they may spend in the intensive care unit of a hospital.
More particularly, premature and critically ill infants, or developmentally challenged infants, experience developmental problems since they are not prepared to handle the stimuli of the extravitro world as a result of their young gestational age, health status or other developmental limitation. It is extremely important to provide a developmentally appropriate environment for such infants to enhance development and limit further complications which may be brought on by developmental deficiencies.
Recent studies, such as Developmental Intervention in the Newborn Intensive Care Unit by Ms. Sally Whitley (a co-inventor of the present invention) NAACOG's Clinical Issues, p. 84-110, 1991, emphasize the effects of the newborn intensive care unit (NICU) environment on newborns. This study indicates that the first goal of a developmental intervention program for NICU patients is to modify the intensive care unit environment to reduce detrimental stimuli to the lowest possible level in order to promote homeostasis. Modification of the NICU environment helps the infants to regulate their physiological and behavioral functioning. Basic and critical components of the environmental modification include providing proper support and positioning of the infant and minimization of stress. When an infant's body is properly supported and the overall environmental stress level is reduced, the infants can properly rest thereby promoting healthful development. If infants do not receive the necessary rest environmental stresses and bodily discomfort can slow the infant's development and possibly cause long-term harm.
Attempts have been made to create devices to support and position infants. A primary goal of infant positioning and supporting devices is to maintain proper body alignment in the prone, supine and side lying positions. The prior attempts at support and positioning infants have not been able to fully accommodate each of the basic infant positions. Further, prior art devices are not easily adjustable to accommodate each infant's initial condition as well as the infant's development based on age, size and condition.
Premature and critically ill infants are subject to skeletal and muscular problems since they often lack sufficient muscular and skeletal development to overcome gravitational forces. This condition, known as hypotonia, may contribute to postures in which the shoulders, hips, arms and legs fall away from the midline of the body. Hypotonia often results in unnatural muscle development and undesirable rotation of bodily joints. As a result, infants suffering from hypotonia may develop irregular structural support and posture.
Another problem that arises due to hypotonia is that the infant may develop behavioral insecurities. Newborn infants typically enjoy, and in fact need, a swaddled or enclosed space in which they are cradled and securely held. This position provides a degree of psychological stability and comfort as the infants make the transition from the womb to the outside world. When infants are hypotonic, they lack the ability to draw their limbs inwardly to achieve this swaddled or fetal position. This problem is exacerbated when infants are prematurely born since the fetal position would be an essential posture if they were still developing in the womb.
Attempts have been made to provide support for hypotonic infants to prevent or reverse the detrimental physical and behavioral development discussed hereinabove. Prior attempts have included positioning these infants on off-the-shelf devices, often designed for other purposes, to provide the necessary support and positioning. Such devices have included water beds, inflatable mattresses and pads, bean bags, gel-foam structures, "egg crate" foam mattress material, sheepskin, rolled linens and diapers, and even infant car seats and carriers. None of the previous attempts have fully satisfied the needs of developmentally challenged infants.
Other problems may arise in addition to hypotonia such as skeletal damage as a result of the premature infant having very fragile malleable limbs. If the limbs are not properly directed in their development, the limbs may take on permanent abnormalities or deformities which could result in structural and physical complications throughout life. Early intervention in supporting and positioning the infant while in the NICU can prevent the need for long-term and expensive physical therapy and physical implements such as splints or surgery to correct abnormalities which develop.
Another problem that arises with premature infants is that their heads tend to develop flattened areas or become elongated. This problem is a result of the immature bone structures in the skull being deformed when the premature infant does not actively or readily change their head position. In an attempt to overcome the flattening problems, soft toroids or "donuts" have been produced. Not all infants are able to tolerate the donuts either as a matter of comfort, or as a matter of the shape of their head, size of their head or any other special requirements. As an additional matter, these donuts tend to position the infant's head out of alignment relative to the rest of the body thereby adding another variable in the alignment and posture problem described hereinabove.
A developmentally challenged infant needs to be positioned and supported by a system which can be configured for his specific needs. The positioning and support system also must be able to be reconfigured as the infant grows or as his needs change so that the support and positioning is always appropriate for his stage of his development or status of his condition. Further, the system must be standardized such that hospital personnel, and even parents can use the system in a predictable manner without complications. It is important for an infant positioning and support system to help reduce or eliminate other environmental stresses such as heat dissipation and to minimize the interference with the infant when the system needs to be reconfigured.
Most of the prior art attempts to overcome the infant positioning and support problems discussed hereinabove introduced or failed to eliminate some form of environmental stress thereby making the device infeasible. For example, the water filled and air filled bags, while providing a degree of support, introduced heat dissipation problems. Heat dissipation is an environmental stress which is highly detrimental to a developmentally challenged infant. It is important, and often critical, to the infant's stability to maintain temperature homeostasis. The water filled bags tend to dissipate heat rapidly thereby decreasing the temperature of the infant and introducing environmental stress. While a heating device may be used in conjunction with the water filled bag, heating devices introduce another variable which must be monitored and controlled. Such heating devices are subject to overheating, underheating, failure to heat, as well as increasing the cost and complexity of the system.
Additionally, prior art devices are often cost prohibitive or required trial and error fitting for each infant and for each configuration for a specific infant. The devices are cost prohibitive because they must be configured and customized for each child. In essence, the prior art devices are often a matter of "redesigning the wheel" for each infant. By redeveloping the positioning and support system for each infant not only is the material cost increased but professional health care provider time is spent thereby substantially increasing the overall cost.
With regard to the problems of trial and error fitting, numerous devices have been designed to satisfy the specific requirements of an individual infant. For example, taped linens and sheepskin rolls may be customized for each child but are difficult to reconfigure, requiring adjustment of the roll size and retaping. Further, the rolled devices required another structure to retain the rolls in the desired supporting desired position. The supporting devices used to wedge the rolls in place introduced yet additional variables and possible failure point in the supporting system.
The prior art devices do not overcome the problems encountered in positioning and supporting developmentally challenged infants. It should be noted that the problems discussed hereinabove are further exacerbated when infants are sedated or otherwise chemically treated such as may be found in postoperative settings. The hypotonia discussed above is magnified by sedatives and these sedated infants may have no muscle tone and therefore are completely exposed to the detrimental effects of gravity.